Clinical Trial: Western Equine Encephalitis Vaccine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 1 Study to Evaluate the Safety and Immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, In Healthy Adults

Brief Summary: This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.

Detailed Summary:

Study Objectives:

Primary: To assess safety of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.

Secondary: To evaluate immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.


Sponsor: U.S. Army Medical Research and Materiel Command

Current Primary Outcome: Subjects Reporting Adverse Events by Vaccination and Sex [ Time Frame: 28 days following each vaccination ]

Original Primary Outcome: Safety [ Time Frame: Through 28 days post vaccination ]

Safety will be assessed from signing of consent document through study completion or withdrawal. Subjects will be assessed for AE's through 28 days after each vaccination. AE's reported by a subject or observed byt the PI will be reocrded individually on the AE sheet and then entered into the electronic AE CRF.


Current Secondary Outcome: Immunogenicity [ Time Frame: Baseline and multiple dates throughout study ]

The primary endpoint used to measure immunogeniciyt of the WEE vaccine, the 80% plaque-reduction neautralization titer (PRNT 80), will be evaluated for subjects in the per protocol population.

The secondary endpoint will be GMT, with 95% CI, of the PRNT 80 for WEE-specific antibodies at each scheduled timepoint.



Original Secondary Outcome: Same as current

Information By: U.S. Army Medical Research and Materiel Command

Dates:
Date Received: July 8, 2010
Date Started: February 2010
Date Completion:
Last Updated: June 5, 2015
Last Verified: June 2015